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Company Overview
Pharvaris NV is a late-stage biopharmaceutical company that specializes in the development of novel, orally administered small-molecule therapeutics, targeting the bradykinin B2 receptor. Leveraging decades of expertise in the treatment of hereditary angioedema (HAE), the company is devoted to providing patients with an innovative alternative to injectable therapies. By focusing on oral delivery, Pharvaris is addressing significant unmet needs in rare, bradykinin-mediated disorders, incorporating advanced clinical research and robust data from multiple studies.
Innovative Therapeutic Strategy
The core of Pharvaris' value proposition lies in its pursuit of an efficacious, safe, and convenient oral therapy for HAE. The company is directly targeting a clinically validated pathway by inhibiting bradykinin signaling with its novel molecules. The most notable compound in the pipeline, deucrictibant, is a highly selective bradykinin B2 receptor antagonist designed for both acute (on-demand) treatment and long-term (prophylactic) prevention of HAE attacks. This dual modality is enhanced by two oral formulations: an immediate-release capsule to achieve rapid symptom relief and an extended-release tablet to provide sustained therapeutic exposure.
Clinical Development and Research Focus
Pharvaris NV has advanced its research with remarkable rigor, evident in the positive data from Phase 2 studies exploring both treatment settings. The ongoing pivotal Phase 3 trials, notably the RAPIDe-3 study for on-demand management and the CHAPTER-3 study for prophylaxis, are critical to establishing the clinical profile of deucrictibant. These studies are designed using robust methodologies and have incorporated metrics such as rapid onset of symptom relief, injectable-like efficacy, and placebo-like tolerability — all of which underscore the innovative nature of their therapeutic approach.
Operational Expertise and Scientific Rigor
At the heart of Pharvaris' operations is a team that combines deep scientific expertise with extensive industry experience. The same core team that contributed to the discovery and approval of icatibant has been instrumental in developing the novel small molecules that form the company's current pipeline. This blend of experience and innovative research ensures that clinical trial designs are both rigorous and reflective of the real-world needs of patients suffering from HAE and potentially other bradykinin-mediated conditions.
Competitive Landscape and Market Position
In the competitive field of rare disease therapeutics, Pharvaris has strategically positioned itself by focusing on an unmet clinical need: offering a patient-friendly, oral alternative to injections. While several therapies in the market continue to rely on injectable routes, Pharvaris’ approach promises ease of administration without compromising efficacy. The company differentiates itself through a commitment to scientific precision, comprehensive clinical evaluation, and an integrated development model that covers both on-demand and prophylactic indications for HAE.
Clinical Data and Key Results
- Robust Clinical Findings: Data from randomized Phase 2 studies have consistently illustrated that treatment with deucrictibant yields rapid, measurable symptom resolution and a marked reduction in attack frequency.
- Patient-Centric Outcomes: In-depth studies have employed patient-reported outcome measures demonstrating improvements in quality of life, disease control, and overall satisfaction with therapy.
- Innovative Formulation Strategy: With the design of both immediate-release and extended-release formulations, Pharvaris underlines its commitment to tailoring its therapeutic offerings to patient needs and clinical demands.
Strategic Research and Pipeline Expansion
Beyond its primary focus on HAE, Pharvaris is exploring additional indications within the realm of bradykinin-mediated disorders. The company is investigating the potential of deucrictibant in acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH) and remains committed to broadening its product portfolio through scientifically driven pipeline expansion. The diverse application of its therapeutic platform allows Pharvaris to maintain a strong and resilient presence in the evolving landscape of rare disease treatment.
Regulatory and Quality Assurance
Maintaining a robust framework for quality and regulatory compliance is a cornerstone of Pharvaris’ operations. The company adheres to international standards in clinical research, ensuring that every study is conducted with the highest level of scientific integrity. Its rigorous approach to clinical development, from preclinical research to Phase 3 trials, reinforces the trust of both regulatory bodies and the patient community.
Concluding Insights
Pharvaris NV represents a paradigm shift in the treatment of hereditary angioedema by transitioning from traditional injectable therapies to an innovative oral regimen. With its focus on the bradykinin B2 receptor, the company offers a unique blend of scientific expertise, patient-first development, and market-driven insights. For investors and industry observers alike, Pharvaris stands out as a comprehensive case study in how targeted drug development and strategic clinical execution can converge to address rare and challenging medical conditions.
The company's comprehensive clinical strategy, backed by positive data from multiple studies, highlights its commitment to improving patient quality of life while maintaining an unwavering commitment to safety, efficacy, and regulatory excellence. By integrating advanced pharmacological research with a strong operational foundation, Pharvaris NV continues to build on its reputation as a critical innovator in the field of biopharmaceutical research and rare disease therapeutics.
Pharvaris (PHVS) has achieved target enrollment in RAPIDe-3, a pivotal Phase 3 study of deucrictibant for HAE attack treatment, while enrollment continues in CHAPTER-3 for HAE attack prophylaxis with topline data expected in 2H2026.
The company received European orphan medicinal product designation for deucrictibant in bradykinin-mediated angioedema treatment. Recent clinical data presentations showed promising results in long-term prophylaxis and rapid treatment of HAE attacks, including upper-airway attacks.
Financial highlights for FY2024:
- Cash position: €281 million (down from €391 million in 2023)
- R&D expenses: €98.6 million (up from €65.6 million in 2023)
- G&A expenses: €47.1 million (up from €31.3 million in 2023)
- Net loss: €134 million or €2.48 per share (compared to €100.9 million or €2.63 per share in 2023)
Pharvaris (Nasdaq: PHVS) announced that the European Commission (EC) has granted orphan designation to its investigational drug deucrictibant for treating bradykinin-mediated angioedema. This follows the U.S. FDA's orphan drug designation granted in March 2022.
The company is currently executing a phase 3 development program to evaluate deucrictibant's efficacy and safety in hereditary angioedema (HAE). As a bradykinin B2 receptor antagonist, deucrictibant aims to block bradykinin effects, potentially offering a broader-acting treatment option for bradykinin-mediated angioedema conditions beyond HAE. The company is also in discussions with regulators regarding a pivotal trial for acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH).
Pharvaris (PHVS) presented long-term clinical data for deucrictibant in treating hereditary angioedema (HAE) at the 2025 AAAAI/WAO Joint Congress. Key findings from the CHAPTER-1 OLE study showed sustained protection from HAE attacks over 1.5 years, with the median proportion of days with symptoms reduced to zero. All participants reaching week 62 reported improved health-related quality of life.
In the RAPIDe-2 extension study, data from seven upper airway attacks showed a median time of 0.9 hours to symptom relief, consistent with results from 328 non-airway attacks. 85.7% of upper airway attacks were effectively treated with a single dose. The maximum exposure to deucrictibant was 20.8 months in the OLE study and 23.7 months overall, with no safety signals observed in both extension studies.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists, has announced its participation in the upcoming Leerink Partners Global Healthcare Conference 2025. The conference will be held from March 10-12, 2025, at the W South Beach Hotel in Miami, FL.
The company, which specializes in treatments for bradykinin-mediated diseases including hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), will provide a live audio webcast of their presentation through their investor relations website. The recording will remain accessible for 30 days following the event.
Pharvaris (NASDAQ: PHVS) has outlined its strategic priorities for 2025, focusing on the clinical development of deucrictibant for hereditary angioedema (HAE) and acquired angioedema (AAE). The company has initiated CHAPTER-3, a pivotal Phase 3 study for HAE prophylaxis, with topline data expected in 2H2026. The RAPIDe-3 Phase 3 study for on-demand HAE treatment continues with topline data anticipated in 1Q2026.
The company plans to expand into AAE treatment with a clinical study planned for 2025. Pharvaris maintains a strong financial position with cash runway extending into 3Q2026. Recent corporate expansion includes key hires in Sales & Marketing and Business Development to support launch preparedness. The company will present at upcoming investor conferences and medical congresses, including AAAAI 2025, where long-term safety and efficacy data for deucrictibant will be presented.
Pharvaris reported Q3 2024 financial results and business updates. The company maintains a strong financial position with €305 million in cash. R&D expenses increased to €25.8 million from €18.5 million YoY, while G&A expenses rose to €12.1 million from €7.7 million. Net loss widened to €41.7 million (€0.77 per share) from €23.6 million (€0.58 per share) YoY.
The company plans to initiate CHAPTER-3, a Phase 3 study for deucrictibant in HAE prophylaxis by year-end 2024. Long-term extension data showed 93% reduction in attacks for prophylaxis and median symptom relief onset of ~1.1 hours for on-demand treatment.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for hereditary angioedema (HAE) attacks, has announced its participation in the Inaugural Guggenheim Securities Healthcare Innovation Conference. The event will take place at the InterContinental Boston from November 11-13, 2024.
The company will participate in a fireside chat on Wednesday, November 13, at 9:30 a.m. ET. A live audio webcast will be available on the Investors section of the Pharvaris website, with the replay accessible for 30 days after the presentation.
Pharvaris (Nasdaq: PHVS) presented seven posters at the 2024 ACAAI Annual Scientific Meeting, showcasing data supporting deucrictibant's development for hereditary angioedema (HAE). The CHAPTER-1 Phase 2 clinical trial demonstrated deucrictibant's efficacy in reducing HAE attack symptoms to 1.7% (40 mg/day) from 14.6% (placebo). The ongoing open-label extension study showed approximately 80% of participants achieved at least a 90% reduction in attack rate. Non-clinical data from bradykinin challenge models in non-human primates supported the drug's pharmacokinetic and pharmacodynamic profile, validating the dosing strategies for both prophylactic and on-demand treatment of HAE attacks.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company, announced the acceptance of multiple abstracts for presentation at upcoming scientific meetings. The presentations will focus on deucrictibant, an oral bradykinin B2 receptor antagonist for treating hereditary angioedema (HAE) attacks.
Key events include:
- Seven e-Poster presentations at the American College of Allergy, Asthma, & Immunology's Annual Scientific Meeting in Boston, October 24-28, 2024
- Three poster presentations at the Canadian Society of Allergy and Clinical Immunology in Banff, Alberta, November 6-9, 2024
- One oral presentation at the Japanese Society of Allergology in Kyoto, October 18-20, 2024
The presentations will cover various aspects of deucrictibant, including long-term safety and efficacy, biomarker assays, and results from clinical trials such as CHAPTER-1 and RAPIDe-2.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists for hereditary angioedema (HAE) attacks, will host a virtual investor event on October 23, 2024, at 10:00 a.m. ET/16:00 CET. The event will focus on:
- Unmet needs in prophylactic and on-demand HAE attack treatment
- Potential of deucrictibant to address these needs
- Current HAE market dynamics
Presenters include medical experts Dr. Michael E. Manning and Dr. Raffi Tachdjian, along with Pharvaris executives Berndt Modig (CEO), Dr. Peng Lu (CMO), and Dr. Wim Souverijns (CCO). A live Q&A session will follow the presentations, and an archived replay will be available for at least 30 days after the event.
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